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NCT00113984 · ClinicalTrials.gov registry record · Phase 1
Vaccine and Antibody Treatment of Prostate Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00113984: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00113984 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00113984, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROSTVAC-F/TRICOM, made from fowlpox virus. GM-CSF is a chemical that boosts the immune system, and anti-CTLA-4 antibody is a protein that may improve anti-tumor activity and the response to the vaccines. DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce prostate specific antigen (PSA)-a protein that is normally produced by the patient's tumor cells. Patients 18 years of age and older with androgen-insensitive prostate cancer that has spread beyond the original site may be eligible for this 7-month study. Candidates must have disease that has worsened despite treatments with hormones and up to one chemotherapy regimen. Their tumor must produce PSA, and they must have no history of allergy to eggs or egg products Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram, pathological confirmation of the diagnosis and presence of the PSA marker, chest x-rays, imaging studies to assess the extent of tumor, and, if clinically indicated, a cardiologic evaluation. Participants receive the priming vaccination on study day 1. After 2 weeks and then again every 4 weeks while on the study, they receive a boosting vaccine. All vaccines are injected under the skin. On the day of each vaccination and daily for the next 3 days, patients receive an injection of GM-CSF to increase the number of immune cells at the vaccination site. On the day of the first six boosting vaccinations, they receive anti-CTLA-4 antibody as an infusion through a vein over 90 minutes. Patients are monitored for safety and treatment response with the following tests a
Interventions
- DRUG Sargramostim
- BIOLOGICAL PROSTVAC-V/TRICOM
- DRUG MDX-010
- BIOLOGICAL PROSTVAC-F/TRICOM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-06-08 |
| Est. Completion | 2011-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113984
The ClinicalTrials.gov registry entry for NCT00113984 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sargramostim is the first listed.
NCT00113984 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00113984 about?
NCT00113984 is a clinical study titled "Vaccine and Antibody Treatment of Prostate Cancer". This study will evaluate the side effects of a fixed dose of vaccine and GM-CSF with increasing doses of anti-CTLA-4 antibody in patients with advanced prostate cancer. The vaccine consists of a "priming vaccine" called PROSTVAC/TRICOM, made from vaccinia virus, and a "boosting vaccine" called PROST...
What is the current status of trial NCT00113984?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2005-06-08. Estimated completion is 2011-12-01.
What interventions are being tested in trial NCT00113984?
The interventions under investigation include: Sargramostim (DRUG), PROSTVAC-V/TRICOM (BIOLOGICAL), MDX-010 (DRUG), PROSTVAC-F/TRICOM (BIOLOGICAL).
Who is sponsoring clinical trial NCT00113984?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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